Home › Device types › OBO
Tomography, Optical Coherence
FDA product code OBO · Class 2 · Ophthalmic
125
Registered devices
15
Adverse events
11
Recalls
66
510(k) clearances
Devices with this code
SPECTRALIS — Heidelberg Engineering GmbHSPECTRALIS — Heidelberg Engineering GmbHSPECTRALIS — Heidelberg Engineering GmbHSPECTRALIS — Heidelberg Engineering GmbHiFusion — OPTOVUE, INC.SPECTRALIS — Heidelberg Engineering GmbHScanning Laser Ophthalmoscope — NIDEK CO.,LTD.iFusion — OPTOVUE, INC.ENVISU C2300 VHR 100V — BIOPTIGEN, INC.iFusion — OPTOVUE, INC.SPECTRALIS — Heidelberg Engineering GmbHANTERION — Heidelberg Engineering GmbHSPECTRALIS — Heidelberg Engineering GmbHRTVue XR Avanti — OPTOVUE, INC.RTVue XR Avanti Scanner — OPTOVUE, INC.3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton — TOPCON CORPORATIONANTERION — Heidelberg Engineering GmbHOCT500 — ESSILOR INTERNATIONALiFusion — OPTOVUE, INC.IMAGEnet 6 — TOPCON HEALTHCARE SOLUTIONS, INC.Avanti — OPTOVUE, INC.SPECTRALIS — Heidelberg Engineering GmbHENVISU C2300 VHR 120V — BIOPTIGEN, INC.SPECTRALIS — Heidelberg Engineering GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-14 | Carl Zeiss Meditec, Inc. | Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance. |
| 2021-11-03 | Haag-Streit USA Inc | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off |
| 2021-07-08 | Carl Zeiss Meditec, Inc. | Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device |
| 2019-07-03 | Heidelberg Engineering GmbH | Error in the default configuration which could lead to the incorrect display of patient master data. |
| 2018-10-16 | Carl Zeiss Meditec, Inc. | Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screw |
| 2017-12-08 | Heidelberg Engineering | FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg Engineerin |
| 2012-09-07 | Optovue Inc. | Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETIN |
| 2012-02-21 | Optovue Inc. | A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version. |
| 2011-03-10 | Carl Zeiss Meditec Inc | A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient |
| 2011-03-10 | Carl Zeiss Meditec Inc | A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first patient |
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